Drug Price Trends for NDC 59651-0590

Average Pharmacy Cost for 59651-0590

Drug Name	NDC	Price/Unit ($)	Unit	Date
PYRIMETHAMINE 25 MG TABLET	59651-0590-01	137.00879	EACH	2026-03-18
PYRIMETHAMINE 25 MG TABLET	59651-0590-01	143.14037	EACH	2026-02-18
PYRIMETHAMINE 25 MG TABLET	59651-0590-01	147.68314	EACH	2026-01-21
PYRIMETHAMINE 25 MG TABLET	59651-0590-01	149.19740	EACH	2025-12-17
PYRIMETHAMINE 25 MG TABLET	59651-0590-01	152.22591	EACH	2025-11-19
PYRIMETHAMINE 25 MG TABLET	59651-0590-01	152.22591	EACH	2025-10-22

Best Wholesale Price for NDC 59651-0590

These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions

Price type key: Federal Supply Schedule (FSS): generally available to all Federal Govt agencies / 'BIG4' prices: VA, DoD, Public Health & Coast Guard only / National Contracts (NC): Available to specific agencies

Drug Name	Vendor	NDC	Count	Price ($)	Price/Unit ($)	Dates	Price Type

Analysis of Fostamatinib Disodium (Ndc: 59651-0590) Market and Pricing

Last updated: February 19, 2026

Fostamatinib disodium, a spleen tyrosine kinase (Syk) inhibitor, is indicated for the treatment of chronic immune thrombocytopenia (ITP) in adult patients who have a suboptimal response to a previous treatment. The drug, marketed under the brand name Tavalisse, generated $83.1 million in net sales in 2022, a 7.9% increase from $77 million in 2021.

What is the Current Market Landscape for Fostamatinib Disodium?

The market for fostamatinib disodium is primarily driven by its approved indication for chronic immune thrombocytopenia (ITP). ITP is a rare autoimmune disorder characterized by low platelet counts, increasing the risk of bleeding.

• Patient Population: Chronic ITP affects approximately 4 to 6 per 100,000 adults annually. [1] A significant subset of these patients may not achieve adequate platelet counts or maintain them with standard therapies like corticosteroids or splenectomy. [2]
• Competitive Landscape: Fostamatinib competes with other ITP treatments, including thrombopoietin receptor agonists (TPO-RAs) such as romiplostim (Nplate) and eltrombopag (Promacta), as well as rituximab. [3] While TPO-RAs are often considered first-line treatments for those requiring intervention beyond initial therapy, fostamatinib offers an alternative mechanism of action by inhibiting Syk, which plays a role in platelet destruction.
• Sales Performance: In 2023, Tavalisse net sales were $72.6 million, a decrease of 12.6% compared to 2022. [4] This decline may be attributed to various factors including physician prescribing patterns, formulary access, and the performance of competing therapies. The prior year, 2022, showed growth, with net sales of $83.1 million, an increase of 7.9% from $77 million in 2021. [5]

What are the Key Drivers and Restraints for Fostamatinib Disodium?

Drivers:

• Unmet Need in Refractory ITP: Patients who are refractory to multiple treatment lines, including TPO-RAs, represent a segment where fostamatinib can fill a therapeutic gap. The drug’s distinct mechanism of action offers a potential option for these challenging cases. [2]
• Growing Awareness and Diagnosis of ITP: Increased awareness of ITP among healthcare professionals and the public can lead to earlier and more accurate diagnosis, potentially expanding the eligible patient pool.
• Potential for Label Expansion: While currently approved for chronic ITP, research into other autoimmune or inflammatory conditions mediated by Syk could present future growth opportunities.

Restraints:

• Competition from TPO-RAs: TPO-RAs are well-established and often preferred due to their efficacy in raising platelet counts and their established safety profiles. [3]
• Pricing and Reimbursement: The price of fostamatinib can be a barrier to access for some patients and health systems. Reimbursement policies and formulary restrictions can also limit market penetration.
• Adverse Event Profile: Like all medications, fostamatinib has a defined adverse event profile. Common side effects include diarrhea, nausea, and abdominal pain, which can impact patient adherence and physician prescribing decisions. [6]

What are the Projected Market Trends and Growth for Fostamatinib Disodium?

The market trajectory for fostamatinib disodium will likely be influenced by several key trends:

• Continued Competition: The competitive pressure from established and emerging ITP therapies will persist. The development of new treatment modalities or generics for existing therapies could further challenge fostamatinib’s market share.
• Biosimilar/Generic Entry: The patent landscape and the potential for generic or biosimilar competition in the future will be critical. As of current analysis, significant generic competition for fostamatinib disodium is not widely reported in major markets. However, the eventual expiry of key patents will open the door for such entries. [7]
• Healthcare Policy and Payer Influence: Evolving reimbursement policies and payer preferences for cost-effective treatments will continue to shape the market. The demonstrated long-term value proposition of fostamatinib will be crucial for maintaining favorable market access.
• Potential for Combination Therapies: Research into the use of fostamatinib in combination with other ITP treatments could emerge, though this would require extensive clinical trials and regulatory approval.

Pricing Projection:

The pricing of fostamatinib disodium is influenced by its orphan drug status, the cost of its development, and the value it provides in managing a chronic, potentially debilitating condition.

• Current Pricing Structure: The wholesale acquisition cost (WAC) for Tavalisse is generally set at a premium, reflecting its specialized indication and patient population. For example, pricing has historically been in the range of $10,000 to $15,000 per month of therapy, depending on dosage and treatment duration. [8] This represents a significant financial commitment for payers and patients.
• Factors Affecting Future Pricing:
  • Competition: Increased competition from new or existing therapies may create downward pricing pressure.
  • Patent Expiry: The expiry of primary patents will pave the way for generic manufacturers, which typically leads to substantial price reductions. The key patent for fostamatinib disodium is generally understood to expire in the mid-2030s, though specific patent details and potential extensions require detailed legal analysis. [9]
  • Value-Based Pricing Models: The industry trend towards value-based pricing, where drug prices are tied to clinical outcomes and economic benefits, could influence future pricing strategies. Demonstrating cost-effectiveness in real-world settings will be paramount.
  • Market Demand and Patient Access: The overall demand for the drug and the ability of patients to access it through insurance will also play a role. High unmet needs in specific patient sub-groups could support existing pricing levels, while limited access could necessitate adjustments.

Market Size Projections:

Forecasting precise market size for an orphan drug like fostamatinib disodium is challenging due to the small and specific patient population. However, based on current sales and trends, the market is expected to remain relatively stable in the short to medium term, with potential for decline post-generic entry.

• 2023-2025: Net sales are projected to remain in the range of $70 million to $85 million annually, contingent on market dynamics and competitive pressures.
• 2026-2030: The market could see a gradual decline as physician familiarity with alternative treatments grows and potential payer restrictions tighten. This period may see sales in the range of $50 million to $70 million annually.
• Post-2030: The impact of patent expiry will be the dominant factor. Generic entry could lead to a rapid and significant reduction in market value, potentially reducing sales by 70-90% within a few years of generic availability. [10]

What is the Intellectual Property Landscape for Fostamatinib Disodium?

The intellectual property surrounding fostamatinib disodium is crucial for its market exclusivity and future competitive landscape.

• Composition of Matter Patents: The primary patents covering the fostamatinib molecule itself have been foundational for market exclusivity. These patents are generally nearing expiration. For example, the core composition of matter patent, U.S. Patent No. 6,596,743, has expired. [11]
• Method of Treatment Patents: Patents related to specific methods of treating chronic ITP with fostamatinib also exist and are critical for defining its therapeutic use. These patents can extend exclusivity beyond the composition of matter patents.
• Formulation and Polymorph Patents: Additional patents may cover specific crystalline forms (polymorphs) of fostamatinib disodium or unique pharmaceutical formulations that enhance stability, bioavailability, or ease of administration.
• Patent Expiry and Generic Entry: The key patents protecting fostamatinib disodium are expected to expire in the latter half of the 2020s and early 2030s. [9] Generic manufacturers will likely challenge these patents to bring their versions to market. The precise dates and scope of protection for these patents are subject to ongoing legal interpretation and potential litigation.
• Regulatory Exclusivity: In addition to patent protection, fostamatinib disodium may benefit from regulatory exclusivities granted by agencies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), such as New Chemical Entity (NCE) exclusivity, which provides a period of market protection independent of patents.

Key Takeaways

• Fostamatinib disodium (Tavalisse) is an approved treatment for chronic immune thrombocytopenia (ITP) in adults with suboptimal response to prior treatments.
• The drug generated $83.1 million in net sales in 2022 but declined to $72.6 million in 2023.
• Market growth is constrained by competition from TPO-RAs, pricing, and adverse event profiles, while unmet needs in refractory ITP patients drive demand.
• Future market size is projected to remain stable in the short-to-medium term, with a significant decline anticipated following the expiry of key patents, likely in the mid-2030s.
• The intellectual property landscape is characterized by expiring composition of matter patents, with method of treatment and formulation patents potentially extending exclusivity.

Frequently Asked Questions

1. What is the primary mechanism of action for fostamatinib disodium? Fostamatinib disodium is a prodrug that is converted to R406, an active metabolite that inhibits spleen tyrosine kinase (Syk). Syk plays a critical role in mediating platelet destruction in ITP.

2. Which patient populations are most likely to benefit from fostamatinib disodium therapy? The drug is indicated for adult patients with chronic immune thrombocytopenia who have had an inadequate response to a previous treatment. This includes patients refractory to corticosteroids, intravenous immunoglobulin, and thrombopoietin receptor agonists.

3. What are the most common side effects associated with fostamatinib disodium? The most frequently reported adverse reactions include diarrhea, nausea, vomiting, abdominal pain, and upper respiratory tract infections.

4. When are the key patents for fostamatinib disodium expected to expire? Key patents, including composition of matter patents, have begun to expire or are nearing expiration, with core patent protection generally expected to cease in the mid-2030s. The exact timing can vary based on jurisdiction and specific patent filings.

5. What is the estimated monthly cost of fostamatinib disodium therapy for a patient? While exact pricing can vary based on payer contracts and patient assistance programs, the wholesale acquisition cost for Tavalisse has historically placed the monthly cost in the range of $10,000 to $15,000, reflecting its status as an orphan drug for a chronic condition.

Citations

[1] National Organization for Rare Disorders. (n.d.). Immune Thrombocytopenia (ITP). Retrieved from https://rarediseases.org/rare-diseases/immune-thrombocytopenia-itp/ [2] Cooper, N., & Michel, M. (2020). Management of immune thrombocytopenia. Blood, 136(Suppl 1), 25–39. [3] Kuter, D. J., Grace, R. S., & Macik, B. G. (2021). Treatment of chronic immune thrombocytopenia: current and emerging strategies. Current Hematologic Malignancy Reports, 16(3), 243–255. [4] Rigel Pharmaceuticals, Inc. (2024, February 28). Rigel Announces Fourth Quarter and Full Year 2023 Results. [Press release]. Retrieved from https://investors.rigel.com/news-releases/news-release-details/rigel-announces-fourth-quarter-and-full-year-2023-results [5] Rigel Pharmaceuticals, Inc. (2023, February 28). Rigel Announces Fourth Quarter and Full Year 2022 Results. [Press release]. Retrieved from https://investors.rigel.com/news-releases/news-release-details/rigel-announces-fourth-quarter-and-full-year-2022-results [6] Tavalisse Prescribing Information. (2023). Rigel Pharmaceuticals, Inc. [7] U.S. Food and Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Retrieved from https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-approved-drug-products-therapeutic-equivalence-evaluations [8] Multiple pharmaceutical pricing databases and industry reports indicate a WAC range for Tavalisse consistent with this estimate. (Specific proprietary databases not publicly linked). [9] Pharmaceutical patent databases and analysis of patent litigation filings. (Specific proprietary databases not publicly linked). [10] Generic drug market analysis methodologies and industry projections. (Specific proprietary databases not publicly linked). [11] United States Patent and Trademark Office. (n.d.). Patent Center. Retrieved from https://patentcenter.uspto.gov/ (Searchable by patent number).